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Sponsor: Hoffmann-La Roche
Conditions: Idiopathic Pulmonary Fibrosis
Interventions: Pirfenidone, Placebo, Sildenafil
Countries: Belgium, Canada, Czechia, Egypt, Germany, Greece, Hungary, Israel
This Phase IIb, randomized, placebo-controlled, multicenter, international study will evaluate the efficacy, safety, and tolerability of sildenafil or placebo added to pirfenidone (Esbriet) treatment in participants with advanced IPF and intermediate or high probability of Group 3 pulmonary hypertension (PH) who are on a stable dose of pirfenidone with demonstrated tolerability. Participants will be randomized to receive 1 year of treatment with either oral sildenafil or matching placebo while continuing to take pirfenidone.
Sex: ALL
Age: 40 Years to 80 Years
Healthy volunteers: No
Study type: INTERVENTIONAL
Inclusion Criteria: * Diagnosis of IPF for at least 3 months prior to Screening * Confirmation of IPF diagnosis by the investigator in accordance with the 2011 international consensus guidelines at screening * Advanced IPF (defined as a measurable carbon monoxide diffusing capacity \[DLCO\] less than or equal to (\<=)40% of predicted value at Screening) and intermediate or high probability of group 3 pulmonary hypertension (PH) * Participants receiving pirfenidone for at least 12 weeks, at a dose in the range of 1602 to 2403 mg/day for at least 4 weeks prior to Screening and must not have experienced either a new or ongoing adverse event of National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) (version 4.03) Grade 2 or higher and considered by the investigator to be related to pirfenidone, or an interruption of pirfenidone treatment of greater than (\>)7 days for any reason * WHO Functional Class II or III at Screening * 6MWD of 100 to 450 meters at screening * Women of childbearing potential and for men who are not surgically sterile agreement to remain abstinent or use of contraceptive measures Exclusion Criteria: * History of any of the following types of PH: Group 1 (PAH); Group 1 (pulmonary veno-occlusive disease and/or pulmonary capillary hemangiomatosis); Group 2 (left-heart disease); Group 3 (due to conditions other than interstitial lung disease, including chronic obstructive pulmonary disease \[COPD\], sleep-disordered breathing, alveolar hypoventilation, high altitude, or developmental abnormalities); Group 4 (chronic thromboembolic pulmonary hypertension); Group 5 (other disorders) * History of clinically significant cardiac disease * History of coexistent and clinically significant COPD, bronchiectasis, asthma, inadequately treated sleep-disordered breathing, or any clinically significant pulmonary diseases or disorders other than IPF or PH secondary to IPF * History of use of drugs and toxins known to cause PAH, including aminorex, fenfluramine, dexenfluramine, and amphetamines * FEV1/FVC ratio less than (\<) 0.70 post bronchodilator; SpO2 saturation at rest \<92% with \>= 6 liters (L) of supplemental oxygen at Screening * Extent of emphysema greater than the extent of fibrotic changes (honeycombing and reticular changes) on any previous high-resolution computed tomography (HRCT) scan, in the opinion of the Investigator * Smoked tobacco within 3 months prior to screening or is unwilling to avoid tobacco products (cigarettes, pipe, cigars) throughout the study * Illicit drug or significant alcohol abuse * Electrocardiogram (ECG) with a heart-rate corrected QT interval (corrected using Fridericia's formula \[QTcF\]) \>=500 milliseconds (ms) at screening, or a family or personal history of long QT syndrome * Exclusion criteria based on pirfenidone reference safety information: 1. participants with a history of angioedema due to pirfenidone; 2. concomitant use of fluvoxamine * Exclusion criteria based on sildenafil reference safety information: 1. co-administration with nitric oxide donors or organic nitrates, phosphodiesterase-5 (PDE5) inhibitors, guanylate cyclase stimulators, and most potent of the Cytochrome P450 3A4 (CYP3A4) inhibitors; 2. loss of vision in one eye because of non-arteritic anterior ischemic optic neuropathy (NAION); 3. use of an alpha-blocker; 4. participants with bleeding disorders or active peptic ulceration; 5. known hereditary degenerative retinal disorders such as retinitis pigmentosa; 6. galactose intolerance
- Brussels, Belgium
- Brussels, Belgium
- Edegem, Belgium
- Leuven, Belgium
- Liège, Belgium
- Mont-godinne, Belgium
- Kingston, Ontario, Canada
- Montreal, Quebec, Canada
- Ste. Foy, Quebec, Canada
- Praha 4 - Krc, Czechia
- Alexandria, Egypt
- Cairo, Egypt
- Cairo, Egypt
- Coswig, Germany
- Donaustauf, Germany
- Essen, Germany
- Fulda, Germany
- Giessen, Germany
- Heidelberg, Germany
- Immenhausen, Germany
- München, Germany
- Athens, Greece
- Chaïdári, Greece
- Heraklio, Greece
- Budapest, Hungary
- Budapest, Hungary
- Beersheba, Israel
- Haifa, Israel
- Jerusalem, Israel
- Jerusalem, Israel
- + 26 more on CT.gov